IRB Manager_____________________________________________
Investigational New Drug/ Investigator Checklist
Protocol title:
PI name:
Date:
Please complete and submit this checklist with your IRB protocol submission packet. This checklist serves as a guide to SponsorInvestigators in determining and documenting information required by the IRB related to the use of an Investigational New Drug (IND)
which falls under the FDA regulations (21 CFR312). (*Sponsor-Investigator is the individual who initiates and also conducts the
study/clinical investigation. Typically this is the Principal Investigator (PI). A sponsor-investigator must comply with
regulatory requirements applicable to both sponsors and clinical investigators (21 CFR312.3)
When a drug is being used in a research study, an IND may be required. Some studies may be exempt from requiring an IND (21
CFR 312.2) if certain criteria are met. Please consult the cited regulations for additional information on exemptions.
Attached to this form is a flowchart that may also be helpful in determining if an IND is required.
a.
HRPP USE ONLY:
Confirm information
for IRB review,
(based on protocol
submission and
checklist) noting a
check mark
Drug name____________________________(Investigations with multiple
drugs must submit a separate form for each drug)
Please include drug/package insert or other documentation that
describes the drug/usage/population/side effects, etc.
.
b
Is the drug/biologic product lawfully marketed in the US?
Yes
No
c
Is there any intent to report the findings of your investigation to
the FDA as a well-controlled study in support of a new indication
or any other significant change in the labeling of the drug?
Yes
No
d
Is the study intended to support a significant change in the
advertising of the drug?
Yes
No
e
Will the investigation involve a change in any of the following factors:
Yes
No
Yes
No
Yes
No



Dosage level (either raising or lowering dose, frequency
or duration compared to approved label)
Patient population
Any other factor that significantly increases (or decreases
the acceptability of the risk) risk associated with the use
of the drug product (21 CFR 312.2(b) (1)(iii)).
f
Is the Investigation intended to promote or commercialize the
drug product (21 CFR part 312.7)?
Yes
No
g
Is a waiver of documentation of informed consent being requested?
Yes
No
PI
FDA
If ANY OF THE SHADED BOXES HAVE BEEN CHECKED, AN IND
APPLICATION TO THE FDA IS LIKELY REQUIRED.
h
If you have obtained an IND from the FDA please provide the IND #:
________________________________________
i
If it has been determined that an IND is NOT required, please indicate if this
determination was made by the PI or the FDA.
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New Drug/IND effective 3/21/16
IRB Manager_____________________________________________

If the drug has not been evaluated by the FDA, the IRB may assess
the drug’s risks and make a determination of exemption from IND
requirements.
Please provide/attach supporting documentation, e.g., letter
from the FDA, package insert, or other information that may
provide support for a determination that an IND is not required.
j
k
Please provide the plan to securely obtain store, dispense/use, and dispose
of the drug. Attach a separate document that includes this information or
note the location/section/page # where this information may be found in the
protocol
The informed consent process/document must include a statement
describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained and the possibility that the FDA may inspect
the records. (21 CFR 50.25 (a) (5))
Is the study an applicable clinical trial?
“Applicable clinical trials” generally include:
(1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1
investigations, of a product subject to FDA regulation;
l
(2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility
studies, and pediatric postmarket surveillance.
Complete statutory definitions and more detailed information on the NIH’s current
thinking about the meaning of “applicable clinical trials” may be found here:
“Elaboration of Definitions of Responsible Party and Applicable Clinical Trial”.
Yes
No
Yes
No
If “Yes” go to “p” .
m
Is the clinical trial registered on Clinicaltrials.gov?

Under federal regulation 21 CFR 50.25(c) the following statement
must be reproduced word-for-word in informed consent documents
for applicable clinical trials that began after March 7, 2012:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by US Law. This Web site will not include information that can identify you. At
most, the Web site will include a summary of the results. You can search this Web site
at any time”
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New Drug/IND effective 3/21/16